益气温阳法治疗面瘫的临床研究

Clinical Study on Yiqiwenyang Therapy for Treatment of Facial Paralysis

目的:评价益气温阳法治疗面瘫的疗效和安全性。方法:将180例面瘫患者随机分为益气温阳药敷治疗组60例、针刺对照组60例和针刺加药敷组60例,疗程均为40天。结果:对总体疗效而言,意向性分析(intention-to-treat,ITT)结果显示3个组总有效率分别为86.67%、90.00%和95.00%,方案数据分析(per-protocol population,PP)结果显示3个组总有效率分别为89.29%、90.91%和96.55%,总体疗效差异具有临床和统计学意义(P<0.05)。但益气温阳药敷治疗组与针刺对照组疗效比较差异无统计学意义(P>0.05),两个组的疗效具有临床上的非劣性(P<0.05)。ITT分析与PP分析结果一致。临床观察中未发现益气温阳药敷治疗组明显毒副作用和不良反应。结论:益气温阳法治疗面瘫安全有效,值得推广应用。

Objective： To assess the efficacy and safety of Yiqiwenyang therapy in the treatment of facial paralysis. Methods： One hundred and eighty cases of facial paralysis were randomly divided into a Yiqiwenyang therapy sticking group （ n = 60）, a routine acupuncture group （ n = 60） and a routine acupuncture combination Yiqiwenyang therapy sticking group（ n = 60）. The therapeutic course for three groups was forty days. Results ： All the results were analyzed on the basis of intention - to - treat and per- protocol population. In the Yiqiwenyang therapy sticking group, the effective rates were 86.67% and 89.29% respectively. In the routine acupuncture group, the effective rates were 90.00% and 90.91% respectively. In the routine acupuncture combination Yiqiwenyang therapy sticking group, the effective rates were 95.00% and 96.55% respectively. There was significant difference between in the three groups, P 〈0.05. But the effective rates of Yiqiwenyang therapy sticking group and routine acupuncture group, there was no significant difference between in the two groups. The efficacy of between two groups was noninferiority, P 〈 0.05. ITr and PP analysis revealed similar results. No adverse effect was found in the clinical observation. Conclusions ： Efficacy and safety of Yiqlwenyang therapy in the treatment of facial paralysis.